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ICMJE臨床試験データ共有の声明の背景と今後の課題
https://repo.qst.go.jp/records/48819
https://repo.qst.go.jp/records/4881993428377-a7a3-4cde-8075-0cbfc363549b
| Item type | 学術雑誌論文 / Journal Article(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2018-04-26 | |||||
| タイトル | ||||||
| タイトル | ICMJE臨床試験データ共有の声明の背景と今後の課題 | |||||
| 言語 | ||||||
| 言語 | jpn | |||||
| 資源タイプ | ||||||
| 資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
| 資源タイプ | journal article | |||||
| アクセス権 | ||||||
| アクセス権 | metadata only access | |||||
| アクセス権URI | http://purl.org/coar/access_right/c_14cb | |||||
| 著者 |
栗原, 千絵子
× 栗原, 千絵子× 齊尾, 武郎× 栗原 千絵子 |
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| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | Background：In January 2016, the International Committee of Medical Journal Editors (ICMJE）proposed a draft report (Proposal) on clinical trial data sharing（CTDS） for public consultation. After that, in June 2017, the ICMJE issued a statement (Statement) on CTDS; however, the reason why it was issued needs further explanation. Methods：Non-systematic, narrative review of literature concerning the ICMJE statements and CTDS. Results：In comparison of the Proposal and Statement, both of them lack a description on the disadvantages of CTDS. The Statement clearly specified 7 items on data sharing to be disclosed in any manuscripts reporting the results of clinical trials submitted to the ICMJE journals. Advantages of CTDS explained in the Proposal are mainly endorsing research integrity which are in line with past activities of the ICMJE. Many academic -pharmaceutical organizations, as well as a regulatory authority and prestigious medical journals, already have fostered a CTDS policy. Recent progress of individual participant data metaanalysis (IPD-MA) demands CTDS. Conclusions：CTDS might improve both the transparency and integrity of clinical trials and quality of meta-analysis. |
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| 書誌情報 |
臨床評価 巻 45, 号 2, p. 481-492, 発行日 2017-08 |
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